ADMA Biologics, Inc.

Rule Changes

As of May 2026: Manufacturer of ASCENIV; commercial beneficiary of label expansion

For seven years, an immune therapy made from antibody-rich human plasma was available only to teenagers and adults. On May 4, 2026, the FDA extended ADMA's ASCENIV to children as young as two, ending the reliance on off-label or alternatives.

Updated May 31